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Design By Datum

Medical device
design and development.

Transforming concepts into compliant medical devices.

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Choose a trusted design partner.

We have extensive experience designing medical devices, test equipment, and electronics enclosures.

Working closely with electronics engineers and healthcare technology experts, we create user centred, hygiene-focused products that perform reliably in clinical environments. 

Why work with us on your next medical device?

  • Compliance first mindset - Designs aligned with ISO 13485, FDA, and IEC standards.
  • User safety & comfort - Ergonomic solutions that make devices intuitive for clinicians and patients.
  • Hygienic & durable - Materials and structures optimised for sterilisation and repeated use.
  • Seamless collaboration - Flexible support that integrates with your R&D team.

How we support your development.

Our approach & design services provide an end to end solution for established businesses and start-ups. 

Concept and Feasibility

Idea Generation, exploration and selection.

Explore early-stage ideas with compliance, built in.

3D CAD Design Detail

Defining features and mechanical structure.

Robust CAD models developed for accuracy and reliability.

Prototype and Test

Functional prototypes for evaluation.

 Validate usability and performance through iteration.

Design for manufacture

Optimisation for cost and efficiency.

Preparing designs for scalable production methods.

Medical Device Case Studies

Rapid Test Digital

Disposable Lateral Flow Assay Reader

Nano Tesla DX

MIDS Handheld Cardiac Test 

Rapid Test Digital

Point of Care Coagulation Meter

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We understand the balance between innovation, compliance, and speed to market. Whether you’re developing a breakthrough diagnostic tool or refining a medical enclosure, our team is here to help.

 

Book a consultation today and take the first step toward launching your next compliant, market-ready medical device.

    What it’s like to work with Design by Datum

    We’re trusted by businesses across the UK and Europe. Here’s what some of our clients have to say about working with us:

    “The team at Design by Datum did a great job to quickly understand our brand, our product and created production ready design work that our customers love. They considered the details, but kept in mind the big picture throughout the process.”
    Andrew Byatt MD @ Blaze Entertainment
    "Throughout this wide-ranging project, DBD has been meticulous and resourceful, personable and adaptable. They have pushed the selected concept all the way through to the cusp of volume production. Without hesitation, I would choose to work with Design By Datum again."
    Andrew HardyHead of Engineering @ Able System
    “Extremely professional, laid out a schedule of work with pricing and they delivered exactly what I needed on time in full which allowed me to develop and commercialise my products. Genuinely couldn’t have been happier. ”
    Toby GlynnFounder @ Paradus Systems
    "Designs were sent back to me extremely quickly and the digital sketches were absolutely stunning. Lovely guys to work with and will be utilising their expertise again! Can’t recommend enough."
    Jimi FrielDirector @ Motus Luggage

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